MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
MIAMI, FL / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.
MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End
Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse findings, clearing a critical milestone as the Company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.
MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025.
MIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain
Promising Preclinical Results Position Ketamir-2 as a Potential Breakthrough Therapy That Surpasses Current Treatments, With Results to Be Presented at the Pain Therapeutics Summit in Boston MIAMI, FL / ACCESSWIRE / October 28, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, announces compelling new preclinical findings showing that Ketamir-2, a novel oral ketamine analog, achieves 60% greater efficacy than the FDA-approved neuropathic pain treatment gabapentin in reducing chemotherapy-induced pain. These results build on earlier successes across various pain models, further validating Ketamir-2's potential to set a new standard in pain management.
MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study
MIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is excited to announce that its novel oral ketamine analog, Ketamir-2, has shown greater pain relief compared to FDA-approved treatments Gabapentin (Neurontin) and Pregabalin (Lyrica). Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications.
MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024
Conference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic pain MIAMI, FL / ACCESSWIRE / September 27, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company developing innovative therapies for neurologic and neuropsychiatric disorders, today announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA (the "Summit"). The presentation, entitled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models.
MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025
MIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, today announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.
MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA
MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, announced today that it has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) and anticipates the meeting to occur in November 2024.
MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough Study
Study Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain Thresholds MIAMI, FL / ACCESSWIRE / August 26, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is proud to announce a major breakthrough in the treatment of neuropathic pain. A recent pre-clinical study in rats demonstrated that its novel oral ketamine analog, Ketamir-2, produced a significant reversal of neuropathic pain, induced by nerve ligation, culminating in a 100% normalization of pain thresholds at the highest dose.
MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End
MIAMI, FL / ACCESSWIRE / August 19, 2024 / MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) "MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, is pleased to provide a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone: the submission of its Investigational New Drug (IND) application by the end of the year. This update highlights the company's strategic progress, significant scientific breakthroughs, and the expertise driving its innovative drug candidates toward clinical trials.
MIRA Pharmaceuticals Unveils Ketamir-2's Principal Metabolite: Nor-Ketamir - a Longer-Acting, Brain Penetrating and Selective Compound Acting on the NMDA PCP Receptor
This breakthrough in bioavailability and formulation showcases the potential for advanced, at home neurological treatments. MIAMI, FL / ACCESSWIRE / August 12, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA Pharmaceuticals, a leading pre-clinical-stage pharmaceutical company unveiled new preclinical data providing further insights into the mechanism of action of its innovative drug candidate, Ketamir-2's principal metabolite, Nor-Ketamir-2.
MIRA Pharmaceuticals Announces Positive Discovery of Ketamir-2's Selective NMDA Binding Mechanism of Action
Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog MIAMI, FL / ACCESSWIRE / July 25, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new insights garnered from additional, recently received preclinical study data regarding the mechanism of action and toxicology data for its novel oral ketamine analog, Ketamir-2. Ketamir-2 is MIRA's drug candidate being investigated as a potential treatment for neurological and neuropsychiatric disorders.
